U.s. Halts 1st Altered Genes Sale

WASHINGTON — The Department of Agriculture has suspended the license and halted the sale of the first live genetically-altered virus to be released into the environment.

The action Tuesday to suspend the license for two weeks came in response to a petition from a Washington-based group that charged that the department had failed to follow federal guidelines for allowing live genetically-altered microorganisms to be released into the environment. The petition, filed Monday by the Foundation on Economic Trends, called for the license to be revoked.

The virus, which has one gene snipped from its genetic code, has been marketed since January as a vaccine to eradicate an outbreak of pseudorabies, a devastating herpes disease in swine that is spreading across the Middle West.

Bert W. Hawkins, the administrator of the Agriculture Department division that licensed the gene-altered virus, said in a letter to the foundation that he was suspending the license and sale of the vaccine until April 22. In that time, he said, his staff would document the procedures that led to its decision to approve the license.

``We didn`t follow the administrative details,`` said Hawkins, who heads the Animal and Plant Health Inspection Service. ``We ran all the environmental analyses, but we really didn`t do as good a job as we should have in keeping an administrative paper trail in documenting each step. I decided it would be better if we backed up, put it on hold, and let the smoke clear.``

Last fall, the vaccine`s manufacturer, the Omaha-based Biologics Corp., gained the Department of Agriculture`s approval to field-test the gene-altered virus in swine herds in three states.

The license, the world`s first to market a living genetically-engineered organism to be used in agriculture, was approved by the health inspection service on Jan. 16.

The Foundation on Economic Trends and its president, Jeremy Rifkin, contended that the decision violated the national environmental policy, which requires a thorough assessment of any major federal action that could affect the environment.

On Monday, Dr. Orville G. Bentley, assistant agriculture secretary for science and education, said the inspection service had erred by failing to notify the department`s Recombinant DNA Research Committee that it was about to approve field tests and to license the gene-altered virus. The committee of experts, formed eight years ago, meets periodically to review research that might lead to field tests of gene-altered organisms.

Hawkins and other scientists in the inspection service have insisted that they followed all the rules and procedures necessary for allowing the gene-altered virus to be marketed as a vaccine.

But in a letter sent Tuesday to Edward Lee Rogers, the lawyer for the foundation, Hawkins said he was suspending the license and sales of the vaccine until his staff had time to thoroughly document all the procedures scientists followed that led to the decision to approve the field tests and marketing license.

Hawkins said he was taking the action despite his feeling that the procedures for approving the gene-altered vaccine were ``scientifically sound and consistent with departmental procedures.``

According to veterinarians, the gene-altered vaccine is safer than other kinds of conventional vaccines because a key enzyme that permits the pseudorabies virus to grow in neural tissues was snipped from its genetic code. The single gene deletion weakens the virus, making it an excellent vaccine, they said.